Ineffectual recalls of medical devices have proved deadly

Hospital administrators say system needs repair

some blame bureaucracy

May 27, 2002|By Tom Pelton | Tom Pelton,SUN STAFF

A 5-year-old boy is crushed to death by a defective hospital bed because a recall notice sat unread on a desk. An attorney dies when a faulty surgical tool inflates his skin and blasts air into his brain because another warning wasn't heeded. A manufacturer tries to recall faulty heart valves but can't find 40 percent of the patients with them.

Administrators at many hospitals complain that the U.S. system for recalling defective medical devices is flawed and itself should be recalled and repaired.

More than 1,000 of the 80,000 medical instruments used in the United States are recalled every year. But because the recalls are run by manufacturers with little government oversight, they are often ineffectual, leading to deaths and injuries.

Some doctors complain that recalls of expensive consumer products work better than recalls of medical instruments.

"It doesn't make any sense. We get better recall notices for our cars than our medical devices," said Dr. Steven Schonfeld, director of pulmonary medicine at Sinai Hospital in Baltimore. "There has to be a much more rigorous process that we could use for device recalls."

The most recent problem revolved around Olympus America Inc., a manufacturer of lung examination instruments called bronchoscopes.

On Nov. 30, the company sent 4,700 recall notices to hospitals across the country because the instruments had a defect that sometimes harbored pseudomonas and allowed the dangerous bacteria to spread among patients. But officials at Johns Hopkins and several other hospitals said in March that their notices were sent to the wrong addresses, and 60 percent of the bronchoscopes nationwide continued to be used more than three months after the warning.

One hundred patients at Johns Hopkins tested positive for pseudomonas after bronchoscopies, although it remains unclear how many of these results were accurate and how many had enough in their lungs to cause illness. Hopkins administrators say they are investigating whether two to five patients died from bacteria spread by the scopes.

`Common problem'

"We've had many, many cases of recall notices being sent to the wrong place. It's a common problem," said Maryanne Spicer, director of corporate compliance at Massachusetts General Hospital in Boston. "The recall system should really be improved."

Sometimes communication breakdowns are the fault of unwieldy hospital bureaucracies, federal regulators say, with important recall notices becoming lost in billing departments or on loading docks.

But manufacturers also cause problems by sending registered letters to old addresses based on outdated billing or delivery databases, according to hospital administrators.

In addition, companies face a conflict of interest when they write warnings about their own products, and they tend to soft-pedal their mistakes and blame the users in often-ambiguously worded notices, critics say.

"It's obviously a problem," said Dr. David Kirschke, an investigator with the federal Centers for Disease Control and Prevention. "I would hope that word gets out to hospitals in some more efficient and effective way in the future."

Kirschke concluded in September that a loose part on Olympus bronchoscopes was the cause of 17 positive tests for pseudomonas among patients at a hospital in Nashville, Tenn. Defective caps on the scopes harbored the bacteria and made the instruments impossible to clean, Kirschke said.

But the company, in the Nov. 30 recall letter, blamed poor washing of the device by hospitals and gave mixed signals on the urgency of the problem.

Olympus' notice told hospitals to "return the bronchoscope at your convenience" so that the company could "upgrade" the device. After being criticized by hospitals and the Food and Drug Administration for this ambiguous language, Olympus issued a second recall notice with a stronger warning Feb. 27.

Dr. David Rorison, senior vice president for medical affairs at the University of Maryland Medical System, explained the difficulties in relying on manufacturers to sound the alarm about their own products.

`Alert but not alarm'

"The current system puts companies in the situation where they kind of want you to know about the problem, but they don't want you to know they are responsible for it," Rorison said. "They want to alert you but not alarm you and not implicate themselves."

Complaints about medical device recalls aren't new. A 1998 report by the U.S. General Accounting Office, the investigative arm of Congress, concluded that less than a third of 54 recalls of medical devices tracked between 1994 and 1996 were completed within the six months required by the FDA.

In contrast, about 72 percent of recalled cars and trucks are successfully returned for modification, the National Highway Traffic Safety Administration says.